Phase III Study Comparing Sequential Versus Alternate Administration of Cisplatin-Etoposide and Topotecan as First-line Treatment in Small Cell Lung Cancer

• Published in: Anticancer research Vol. 30; no. 7; pp. 3031 - 3038
• Main Authors: BAKA, Sophia, AGELAKI, Sophia, ANDROULAKIS, Nikolaos, VAMVAKAS, Lambros, KALBAKIS, Kostas, MAVROUDIS, Dimitris, GEORGOULIAS, Vassilis, KOTSAKIS, Athanasios, VESLEMES, Marinos, PAPAKOTOULAS, Pavlos, AGELIDOU, Maria, AGELIDOU, Athina, TSAROUCHA, Emily, PAVLAKOU, Georgia, GEROGIANNI, Aleka
• Format: Journal Article
• Language: English
• Published: Attiki International Institute of Anticancer Research 01.07.2010
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Biological and medical sciences; Cisplatin - administration & dosage; Cisplatin - adverse effects; Disease Progression; Drug Administration Schedule; Etoposide - administration & dosage; Etoposide - adverse effects; Female; Humans; Lung Neoplasms - drug therapy; Male; Medical sciences; Middle Aged; Patient Compliance; Pneumology; Small Cell Lung Carcinoma - drug therapy; Survival Rate; Topotecan - administration & dosage; Topotecan - adverse effects; Tumors; Tumors of the respiratory system and mediastinum; Antineoplastic agent; Phase III trial; Lung cancer; Bonchopulmonary small cell carcinoma; Podophyllotoxin derivatives; Isomerases; Cancerology; Sequential; Bronchus disease; Antimitotic; Topoisomerase I inhibitor; Platinum II Complexes; Camptothecin derivatives; DNA topoisomerase (ATP-hydrolysing); Lung disease; SCLC; Enzyme; Respiratory disease; DNA topoisomerase; Enzyme inhibitor; Etoposide; Topotecan; alternate; Topoisomerase II inhibitor; Malignant tumor; Cisplatin; First line treatment; Alkylating agent; Comparative study; Cancer
• ISSN: 0250-7005; 1791-7530

To compare the efficacy and tolerance of sequential versus alternate front-line administration of cisplatin-etoposide (PE) and topotecan (T) in patients with extensive stage small cell lung cancer (SCLC). Patients were randomized to receive either 4 cycles PE (cisplatin 80 mg/m(2) i.v. day 1 and etoposide100 mg/m(2)/d i.v. days 1-3 every 21 days) followed by 4 cycles T (1.5 mg/m(2)/d i.v. days 1-5 every 21 days) (arm A, 183 patients) or the same regimens using an alternate sequence (arm B, 181 patients). There was no significant difference in terms of compliance with treatment, overall response rates (51.4% vs. 55.2%; p=0.458), median response duration (4.3 vs. 5.2 months; p=0.780), median time to tumour progression (5.7 vs. 6.4 months; p=0.494), median overall survival (10.9 vs. 9.8 months; p=0.186) and 1-year survival (43.8% vs. 36.5%) between the two arms. The incidence of severe grade 3-4 haematological and grade 2-4 non-haematological (asthenia, mucositis, diarrhoea and neurotoxicity) toxicity was comparable between the two arms. The comparison of sequential versus alternate administration of cisplatin-etoposide and topotecan as front-line treatment of patients with extensive stage SCLC revealed no clinically meaningful differences in terms of efficacy and tolerance.